ReviewInternational journal of clinical practice2010
Safety of sildenafil citrate: review of 67 double-blind placebo-controlled trials and the postmarketing safety database.
Review in International journal of clinical practice, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
40 citing papers in PubMed, 2 syntheses or guidelines pooled it, 161 citations in OpenAlex.
- Pediatric Cardiac Intensive Care Society 2014 Consensus Statement: Pharmacotherapies in Cardiac Critical Care Pulmonary Hypertension.Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies · 2016Guideline
- Sildenafil citrate for erectile dysfunction in patients with multiple sclerosis.The Cochrane database of systematic reviews · 2012Pooled it
- Trial
- Randomised clinical trial: a leucine-metformin-sildenafil combination (NS-0200) vs placebo in patients with non-alcoholic fatty liver disease.Alimentary pharmacology & therapeutics · 2018Trial
- Sildenafil increases muscle protein synthesis and reduces muscle fatigue.Clinical and translational science · 2013Trial
- Oral spray sildenafil in erectile dysfunction: current evidence and clinical perspectives.International urology and nephrology · 2026Review
- Pluripotent stem-cell-based screening uncovers sildenafil as a mitochondrial disease therapy.Cell · 2026Article
- Repurposing PDE5-Inhibitors: Sildenafil Drives Arteriogenesis via Localized Regenerative Inflammation.International journal of molecular sciences · 2026Article
- Suspected Sildenafil-Induced Immune Hemolytic Anemia Precipitating Acute Kidney Injury Requiring Hemodialysis.Cureus · 2025Article
- Development and evaluation of sildenafil/glycyrrhizin-loaded nanofibers as a potential novel buccal delivery system for erectile dysfunction.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2024Article
- Article
- Psychosis beas a rare side effect of sildenafil: a case report.Journal of medical case reports · 2022Article
- Bibliometric and visualization analysis of literature relating to diabetic erectile dysfunction.Frontiers in endocrinology · 2022Article
- The Role of Sildenafil in Treating Brain Injuries in Adults and Neonates.Frontiers in cellular neuroscience · 2022Review
- Novel Emerging Therapies for Erectile Dysfunction.The world journal of men's health · 2021Review
- Established and emerging therapeutic uses of PDE type 5 inhibitors in cardiovascular disease.British journal of pharmacology · 2020Review
- Do Urologists Really Recognize the Association Between Erectile Dysfunction and Cardiovascular Disease?Sexual medicine · 2020Article
- Perception of the association between erectile dysfunction and cardiovascular disease among Chinese physicians: an online survey.The Journal of international medical research · 2020Article
- Psychological Impacts of Male Sexual Dysfunction in Pelvic Cancer Survivorship.Sexual medicine reviews · 2019Review
- Effects of combined extracts of Lepidium meyenii and Allium tuberosum Rottl. on erectile dysfunction.BMC complementary and alternative medicine · 2019Article
Corrections and comments
- Commented on by
Authors and funding
5 authors at 4 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimTo review special safety topics associated with sildenafil and to document the tolerability of 50- and 100-mg doses, overall and by age, in men with erectile dysfunction (ED).
methodsData were collated from 67 double-blind placebo-controlled (DBPC) trials (> 14,000 men) conducted by the manufacturer and from the manufacturer's postmarketing safety database (39,277 patients). The DBPC data were stratified by dose, starting dose and age (> or = 65 and > or = 75 years). Special safety topics included cardiovascular risk, priapism, non-arteritic anterior ischaemic optic neuropathy (NAION), impaired renal and hepatic function, drug interactions (i.e. nitrates, cytochrome P3A4 inhibitors, other ED therapies and alpha-blockers) and incorrect use.
resultsSildenafil was well tolerated at a dose of 50 or 100 mg in men with ED, overall, in those aged > or = 65 years, and in those aged > or = 75 years. Analyses of the databases did not reveal any causal link between sildenafil and cardiovascular events, or any new safety risks relating to cardiovascular events, priapism, NAION, hearing loss or drug interactions. In the small number of men with moderate impairment of renal function or hepatic function who were treated with sildenafil in DBPC trials, the safety profile was similar to that in men with no impairment of renal or hepatic function. Overdose with sildenafil was rare in the ED population. No new safety issues, emerging trends or adverse reactions were identified in conjunction with overdose, dependence, abuse or misuse.
conclusionThis collated review confirms generally the good tolerability and established safety profile of sildenafil 50 and 100 mg in men with ED and reveals no new safety issues.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.